post-bg-627
calendary December 13, 2018

Requirements for efficiency and safety of dietary supplements

In the first article of this heading general principles of certification of dietary supplements within the Customs Union were considered. However, certification is a process that involves an enormous preliminary effort to collect the documents and reports necessary to confirm the effectiveness and safety of a product.

It should be noted that the main document regulating the issues of safety indicators, conditions and processes of production, as well as the procedure of state registration is TR CU 021/2011. (“Biologically active supplements”). However, this document contains a large number of references to other regulatory documents, including MG 2.3.2.721-98 “Determination of safety and effectiveness of dietary supplements to food”.

These guidelines provide definitions of the quality and safety of dietary supplements:

  • The quality of dietary supplements is a set of characteristics that determine consumer properties, efficiency and safety of dietary supplements to food.
  • Safety of dietary supplements means that there is no danger to the life and health of people of present and future generations.

The effectiveness and safety of dietary supplements as well as consumer properties are checked within the framework of a hygienic examination, which includes the following stages:

1.Initial expert evaluation of documents and materials characterizing this product;

2.Identification of the need for necessary research;

3.Conducting a complex of necessary sanitary-chemical, sanitary-microbiological and other types of research;

4.Experimental studies of toxicological, physiological and metabolic effects, confirming the declared profile of dietary supplements;

5.Clinical evaluation of effectiveness;

6.Comprehensive expert evaluation of the results, taking into account the data obtained in the course of research;

Research is carried out in institutions and laboratories accredited in the “Accreditation System for Laboratories of the State Sanitary and Epidemiological Service of the Russian Federation”.

Based on the results of the work, an expert opinion is prepared (the act of hygienic expertise), which is part of the registration dossier provided to the Rospotrebnadzor for subsequent review  (see article — “Biologically active additives”)


  1. TR CU 021/2011
  2. MG 2.3.2.721-98 “Determination of safety and efficiency of dietary supplements to food”.
References:
  1. http://rospotrebnadzor.ru/gosserv/for/11/category/90/5402/

More related posts

new-img-1

Control

Fine for spa resort in Yessentuki

Roszdravnadzor has imposed a fine of 130 thousand rubles on a spa resort in Yessentuki for improper storage of medical products…

03.03.2016
READ ARTICLE
new-img-2

Roszdravnadzor

Roszdravnadzor – patients’ rights

In 2015, Roszdravnadzor restored the rights of more than 460 thousand citizens to effective, accessible, and safe medical…

03.03.2016
READ ARTICLE
new-img-3

Regulation

The certification scheme for medical products hasn’t changed recently

Roszdravnadzor informs that the certification scheme for products in the Russian Federation is determined by Decree of the…

03.04.2016
READ ARTICLE
new-img-4

Control

Fines – Rostov region

In one and a half months of 2016, the Local Agency of Roszdravnadzor in Rostov Region imposed fines of the total amount of…

03.10.2016
READ ARTICLE
new-img-5

Control

Unregistered medical products

Two citizens were fined for selling unregistered medicinal products on the Internet in the Republic of Bashkortostan.

03.10.2016
READ ARTICLE
new-img-6

Control

Unscheduled inspection by roszdravnadzor

Roszdravnadzor started an unscheduled inspection of the Federal State-Funded Institution of Sverdlovsk Region Kirovgrad Central…

03.14.2016
READ ARTICLE
new-img-7

Medical Devices

International medical device regulators forum (IMDRF)

The delegation of the Federal Service for Surveillance in Healthcare headed by Mikhail Murashko, Head of Roszdravnadzor,…

03.17.2016
READ ARTICLE
new-img-8

Pharmaceuticals

Roszdravnadzor has suspended a series of the preparation “Paratsetomol-UBF”

Roszdravnadzor has suspended a series of the preparation “Paratsetomol-UBF” in which pills the metal wire was found.

05.18.2016
READ ARTICLE
new-img-9

Roszdravnadzor

Medical equipment stands idle in the Pskov region

Roszdravnadzor (RZN) statement: the expensive medical equipment for the total amount of 342 million rubles stands idle in…

05.19.2016
READ ARTICLE
new-img-10

Control

Hospital control Jewish autonomous region

Roszdravnadzor has audited the activity of the Regional Budgetary Public Health Facility “Central district hospital of Lenin”…

05.20.2016
READ ARTICLE